Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
Herausgeber: Sharma, Navneet; Shukla, Vikesh Kumar; Arora, Sandeep
Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
Herausgeber: Sharma, Navneet; Shukla, Vikesh Kumar; Arora, Sandeep
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This resource provides a guide to the regulations and standards which govern the international pharmaceutical industry. Featuring explanations of regulations and strategies to maintain compliance, the book covers the key principles of best-practice for laboratory research, manufacturing and distribution.
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This resource provides a guide to the regulations and standards which govern the international pharmaceutical industry. Featuring explanations of regulations and strategies to maintain compliance, the book covers the key principles of best-practice for laboratory research, manufacturing and distribution.
Produktdetails
- Produktdetails
- Verlag: Taylor & Francis Ltd
- Seitenzahl: 272
- Erscheinungstermin: 25. November 2024
- Englisch
- Abmessung: 229mm x 152mm
- ISBN-13: 9781032814124
- ISBN-10: 1032814128
- Artikelnr.: 71237068
- Verlag: Taylor & Francis Ltd
- Seitenzahl: 272
- Erscheinungstermin: 25. November 2024
- Englisch
- Abmessung: 229mm x 152mm
- ISBN-13: 9781032814124
- ISBN-10: 1032814128
- Artikelnr.: 71237068
Navneet Sharma, PhD is an Assistant Professor at Amity Institute of Pharmacy, Amity University, India. Vikesh Kumar Shukla, PhD is an Associate Professor and Centre Head at Amity Institute of Pharmacy, Amity University, India. Sandeep Arora, PhD is a professor and director at the Amity Institute of Pharmacy, Amity University, India.
1. US Pharma Manufacturing Standards: Cfr 210 & 211
2. A Comprehensive Review on the Good Manufacturing Practices Standards:
Directive 91/356 of the European Commission
3. Integration Of Cgmp & Gamp-5 In Pharmaceutical Manufacturing
4. Medical Device and Ivds Global Harmonization Task Force Guidance
Documents
5. Current Scenario and Future Perspective of Good Laboratory Practices
6. Advancing Laboratory Excellence: A Comprehensive Review of Quality
Audits
7. Introduction of Good Automated Laboratory Practices (Galp): Principles
and Comparative Analysis Across Regulatory Authorities - Usfda, Ema, Cdsco,
And Tga
8. A Framework to Understanding E-Records Under 21cfr Part 11
9. Current Trends in Good Distribution Practices (Gdp)
10. Navigating The Pharmaceutical Supply Chain: Ensuring Integrity Amidst
Challenges
11. Optimizing Pharmaceutical Quality: Exploring Out of Specification,
Total Quality Management, Change Control
12. Insights Into the Six Sigma Concept
13. Good Regulatory Practices and Validation Plans in Pharmaceutical
Practices
14. Critical Utility Validation: An Innovative Approach to Pharmaceutical
Best Practices
15. International Council of Harmonization: Reception to Implementation
16. ISO-13485 and Schedule MIII - Quality Management System
2. A Comprehensive Review on the Good Manufacturing Practices Standards:
Directive 91/356 of the European Commission
3. Integration Of Cgmp & Gamp-5 In Pharmaceutical Manufacturing
4. Medical Device and Ivds Global Harmonization Task Force Guidance
Documents
5. Current Scenario and Future Perspective of Good Laboratory Practices
6. Advancing Laboratory Excellence: A Comprehensive Review of Quality
Audits
7. Introduction of Good Automated Laboratory Practices (Galp): Principles
and Comparative Analysis Across Regulatory Authorities - Usfda, Ema, Cdsco,
And Tga
8. A Framework to Understanding E-Records Under 21cfr Part 11
9. Current Trends in Good Distribution Practices (Gdp)
10. Navigating The Pharmaceutical Supply Chain: Ensuring Integrity Amidst
Challenges
11. Optimizing Pharmaceutical Quality: Exploring Out of Specification,
Total Quality Management, Change Control
12. Insights Into the Six Sigma Concept
13. Good Regulatory Practices and Validation Plans in Pharmaceutical
Practices
14. Critical Utility Validation: An Innovative Approach to Pharmaceutical
Best Practices
15. International Council of Harmonization: Reception to Implementation
16. ISO-13485 and Schedule MIII - Quality Management System
1. US Pharma Manufacturing Standards: Cfr 210 & 211
2. A Comprehensive Review on the Good Manufacturing Practices Standards:
Directive 91/356 of the European Commission
3. Integration Of Cgmp & Gamp-5 In Pharmaceutical Manufacturing
4. Medical Device and Ivds Global Harmonization Task Force Guidance
Documents
5. Current Scenario and Future Perspective of Good Laboratory Practices
6. Advancing Laboratory Excellence: A Comprehensive Review of Quality
Audits
7. Introduction of Good Automated Laboratory Practices (Galp): Principles
and Comparative Analysis Across Regulatory Authorities - Usfda, Ema, Cdsco,
And Tga
8. A Framework to Understanding E-Records Under 21cfr Part 11
9. Current Trends in Good Distribution Practices (Gdp)
10. Navigating The Pharmaceutical Supply Chain: Ensuring Integrity Amidst
Challenges
11. Optimizing Pharmaceutical Quality: Exploring Out of Specification,
Total Quality Management, Change Control
12. Insights Into the Six Sigma Concept
13. Good Regulatory Practices and Validation Plans in Pharmaceutical
Practices
14. Critical Utility Validation: An Innovative Approach to Pharmaceutical
Best Practices
15. International Council of Harmonization: Reception to Implementation
16. ISO-13485 and Schedule MIII - Quality Management System
2. A Comprehensive Review on the Good Manufacturing Practices Standards:
Directive 91/356 of the European Commission
3. Integration Of Cgmp & Gamp-5 In Pharmaceutical Manufacturing
4. Medical Device and Ivds Global Harmonization Task Force Guidance
Documents
5. Current Scenario and Future Perspective of Good Laboratory Practices
6. Advancing Laboratory Excellence: A Comprehensive Review of Quality
Audits
7. Introduction of Good Automated Laboratory Practices (Galp): Principles
and Comparative Analysis Across Regulatory Authorities - Usfda, Ema, Cdsco,
And Tga
8. A Framework to Understanding E-Records Under 21cfr Part 11
9. Current Trends in Good Distribution Practices (Gdp)
10. Navigating The Pharmaceutical Supply Chain: Ensuring Integrity Amidst
Challenges
11. Optimizing Pharmaceutical Quality: Exploring Out of Specification,
Total Quality Management, Change Control
12. Insights Into the Six Sigma Concept
13. Good Regulatory Practices and Validation Plans in Pharmaceutical
Practices
14. Critical Utility Validation: An Innovative Approach to Pharmaceutical
Best Practices
15. International Council of Harmonization: Reception to Implementation
16. ISO-13485 and Schedule MIII - Quality Management System